Evaluation of Efficacy of multidomain interventions of diet, exercise, managing of vascular risk factors and cognitive training to prevent cognitive decline in Iranian older adults

Phase 3

Recruiting

Conditions: Major neurocognitive disorder.
Dementia in other diseases classified elsewhere

Registration Number: IRCT20151122025191N3

Lead Sponsor: Department of health and ageing - Department of population, family and school health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 196

Inclusion Criteria

Aged 55 to 74 years.
Having at least one modifiable dementia risk factor from among hypertension, diabetes mellitus, dyslipidemia, obesity, abdominal obesity, abdominal obesity, metabolic syndrome, smoking, educational level less than 9 years, physical inactivity, and social inactivity.
No neurocognitive disorder detected by the psychiatrist with the use of DSM5 criteria at the base time.
The score 85 or more in the Addenbrooke cognitive test at the base time.
Able to independently perform the activities of daily living.
Can read and write in Farsi.
Able to participate in the exercise program safely.
Having a reliable informant who can provide investigators with requested information.
Providing written informed consent.

Exclusion Criteria

Existence of major psychiatric illness such as major depressive disorder.
Existence of other neurodegeneration disease such as Parkinson's disease.
The history of malignancy within the previous 5 years.
The history of cardiac stent or revascularization within the previous 1 year.
Existence of serious or unstable medical disease such as acute or sever asthma, active gastric ulcer, sever liver disease, or sever renal disease.
Existence of sever loss of vision or hearing, or communication disability.
Existence of any conditions preventing cooperation as judged by the study physician.
Existence of significant laboratory abnormality that may result in cognitive impairment.
The simultaneous participation in any other intervention trial.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Addenbrooke's Cognitive Examination Score. Timepoint: at the baseline, and the third and the sixth month after intervention. Method of measurement: Addenbrooke's Cognitive Examination-II Score.;Cambridge Neuropsychological Test Automated Battery. Timepoint: At the baseline, the third and the sixth month after intervention. Method of measurement: CANTAB Cognitive Software.

Secondary Outcome Measures